Trilogy Acetabular Shells with Holes
Medical device recall Z-0775-2013. Published in FDA’s Enforcement Report on Feb 13, 2013.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Feb 13, 2013. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 275,952 units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Some units of Trilogy shells manufactured since March 2009 may be below the lower range of the pore size specification (as low as 28% vs. 30% porosity specification). On 10/31/2012, the firm expanded the recall action to include lots of Uni-Hole Trilogy Acetabular System shells.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Trilogy Acetabular Shells with Holes. The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery for rehabilitating hip damage.
275,952 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
61567730 61558081 61611792 61559843 61567731 61611793 61215883 00369728 00369696 61930401 61459870 61611794 61564135 61201896 61292658 61783434 61915194 00369729 00369680 61921675 61638695 61915195 61906180 61808994 61425796 61580824…
Every code shown here, 1,998 characters
61567730 61558081 61611792 61559843 61567731 61611793 61215883 00369728 00369696 61930401 61459870 61611794 61564135 61201896 61292658 61783434 61915194 00369729 00369680 61921675 61638695 61915195 61906180 61808994 61425796 61580824 61471012 61263144 61201897 00369730 00370028 00370201 00370605 00370449 00369628 61996704 61779026 61533558 61758219 61455810 61452211 61911378 61596869 61734419 61783435 61794928 61201845 61783436 62055820 61580825 61825846 62022693 61580826 61638696 61889255 61263146 61281167 61321048 61329084 61471011 61638699 61896724 61921677 61283615 61309774 61215878 61216899 61638698 61855181 61906445 62052789 61374925 61638697 61199815 61199814 61403503 61412019 61486653 61521911 61533559 61580827 61633747 61817461 61921676 61957085 61263145 61412020 61470969 61486654 61809006 61292660 61237662 61374926 61452210 61528582 61837767 61873598 61930403 61945055 62006515 62052788 00370200 00369694 00370606 61732766 62063917 61374929 61454830 61360114 61500667 61808989 61996705 61734247 61635717 61640790 61920504 61716307 62022695 61215901 61949819 61215902 61397892 61486655 61580830 61635718 61779021 61882566 61638701 61709187 61884425 61201851 61271311 61374927 61454832 61483179 61533563 61761996 61783437 61825847 61832823 61957087 61957088 62038296 61803761 61846473 61873601 61999739 61425778 61439219 61455776 61528584 61533562 61580828 61638702 61640789 61750751 61846472 61878440 61528585 61783438 61945056 62055823 61281168 61283616 61292661 61368469 61439218 61454831 61486656 61533561 61542694 61542695 61580832 61580833 61640786 61640787 61820780 61846474 61860441 61895514 61941700 62063918 61397895 61454829 61709189 61842601 61860440 61867233 61911379 61216902 61263148 61263149 61269930 61271310 61283617 61309777 61374928 61397896 61412021 61497356 61533560 61564136 61580831 61611812 61638703 61716305 61761995 61803760 61808988 61867232 61906446 61921678 61947557 62022696 61825848 61939314 61216901 61260601 61292662 61309776 61329085 61340386…
FDA’s list runs to 15,659 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide Distribution-USA (nationwide) and the countries of Denmark, Germany, Greece, Hungary, Ireland, Italy, Netherlands, Spain, Sweden, UK, Poland, France, Australia, Chile, Canada, India, Japan, New Zealand, Peru, South Africa, Colombia, Ukraine, and UAE.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Sep 14, 2012.
- FDA classified it on Feb 4, 2013.
- FDA’s Enforcement Report published it on Feb 13, 2013.
- FDA terminated it on Jun 20, 2014.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Zimmer, Inc., of Warsaw, IN.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 15,659 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.